Medtronic plc (NYSE: MDT) has received United States
Food and Drug Administration (FDA) approval for a less-invasive implant approach
of its HVAD(TM) System, a left ventricular assist device (LVAD) for patients
with advanced heart failure. The HVAD System is the smallest commercially
available LVAD, and the only LVAD approved in the U.S. for implant via
thoracotomy, a small lateral, surgical incision between the patient’s ribs on
the left side of the chest.
Food and Drug Administration (FDA) approval for a less-invasive implant approach
of its HVAD(TM) System, a left ventricular assist device (LVAD) for patients
with advanced heart failure. The HVAD System is the smallest commercially
available LVAD, and the only LVAD approved in the U.S. for implant via
thoracotomy, a small lateral, surgical incision between the patient’s ribs on
the left side of the chest.
LVADs help the heart pump and increase the amount of blood that flows through
the body. They are typically implanted via median sternotomy, a surgical
procedure in which a vertical incision is made down the middle of the chest,
after which the sternum (or breastbone) is divided.
the body. They are typically implanted via median sternotomy, a surgical
procedure in which a vertical incision is made down the middle of the chest,
after which the sternum (or breastbone) is divided.
FDA approval for HVAD implantation via thoracotomy is based on data from the
LATERAL prospective clinical trial, in which 144 patients, with end-stage heart
failure who were eligible for heart transplant, were enrolled at 26 centers in
the U.S. and Canada. The primary endpoint of the trial demonstrated non-
inferiority of the HVAD implanted in patients via thoracotomy, where survival at
six months free from disabling stroke or device explant or exchange due to
malfunction was achieved in 88.1 percent of patients. Since the success outcome
exceeded the pre-specified performance goal of 77.5 percent, the trial achieved
its primary endpoint (p=0.0012). The key secondary endpoint revealed a
significant reduction in total length of hospital stay, from an average of 26.1
days down to 18 days (p<0.001). Overall survival among patients receiving an
HVAD via the thoracotomy procedure was 88.8 percent at one year. Detailed
outcomes of the LATERAL trial and its secondary endpoints were presented at The
International Society for Heart and Lung Transplantation (ISHLT) 2018 Scientific
Sessions.
LATERAL prospective clinical trial, in which 144 patients, with end-stage heart
failure who were eligible for heart transplant, were enrolled at 26 centers in
the U.S. and Canada. The primary endpoint of the trial demonstrated non-
inferiority of the HVAD implanted in patients via thoracotomy, where survival at
six months free from disabling stroke or device explant or exchange due to
malfunction was achieved in 88.1 percent of patients. Since the success outcome
exceeded the pre-specified performance goal of 77.5 percent, the trial achieved
its primary endpoint (p=0.0012). The key secondary endpoint revealed a
significant reduction in total length of hospital stay, from an average of 26.1
days down to 18 days (p<0.001). Overall survival among patients receiving an
HVAD via the thoracotomy procedure was 88.8 percent at one year. Detailed
outcomes of the LATERAL trial and its secondary endpoints were presented at The
International Society for Heart and Lung Transplantation (ISHLT) 2018 Scientific
Sessions.
“We have demonstrated that a thoracotomy is a safe and effective implant
technique for the HVAD System, which gives physicians added flexibility in
treating a broad range of patients,” said Edwin McGee, Jr., M.D., professor and
director, Heart Transplant & Ventricular Assist Device Program, Loyola
University Medical Center, Maywood, Ill., and principal investigator of the
LATERAL trial. “Implanting the HVAD via thoracotomy preserves the chest for a
subsequent procedure that patients may need, such as a heart transplant. It also
has been shown to result in shorter hospital stays.”
technique for the HVAD System, which gives physicians added flexibility in
treating a broad range of patients,” said Edwin McGee, Jr., M.D., professor and
director, Heart Transplant & Ventricular Assist Device Program, Loyola
University Medical Center, Maywood, Ill., and principal investigator of the
LATERAL trial. “Implanting the HVAD via thoracotomy preserves the chest for a
subsequent procedure that patients may need, such as a heart transplant. It also
has been shown to result in shorter hospital stays.”
The HVAD System is the only LVAD approved in the U.S. and Europe for implant via
a thoracotomy as well as a median sternotomy. It is approved to treat patients
with advanced, refractory heart failure as a bridge to cardiac transplantation
and as destination therapy in patients for whom subsequent transplantation is
not planned.
a thoracotomy as well as a median sternotomy. It is approved to treat patients
with advanced, refractory heart failure as a bridge to cardiac transplantation
and as destination therapy in patients for whom subsequent transplantation is
not planned.
In addition to this approval, new surgical implant tools tailored to assist
physicians with the thoracotomy approach for the HVAD System are now available
in the U.S. and in CE Marked countries.
physicians with the thoracotomy approach for the HVAD System are now available
in the U.S. and in CE Marked countries.
“The thoracotomy approach showed significant improvements in patients’ quality
of life and functional capacity, supported by strong safety and effectiveness
data from the study,” said David Steinhaus, M.D., vice president and general
manager of the Heart Failure business, which is part of the Cardiac and Vascular
Group at Medtronic. “Further, the added flexibility for implant approach offers
a unique advantage of the HVAD System.”
of life and functional capacity, supported by strong safety and effectiveness
data from the study,” said David Steinhaus, M.D., vice president and general
manager of the Heart Failure business, which is part of the Cardiac and Vascular
Group at Medtronic. “Further, the added flexibility for implant approach offers
a unique advantage of the HVAD System.”
The Medtronic portfolio of therapies, diagnostic tools and services for patients
suffering from heart failure includes CRT devices, including MR-conditional CRT-
Ds and CRT-Ps; mechanical circulatory support therapy for advanced heart failure
patients; heart failure diagnostics; and meaningful expert analysis through
Medtronic Care Management Services.
suffering from heart failure includes CRT devices, including MR-conditional CRT-
Ds and CRT-Ps; mechanical circulatory support therapy for advanced heart failure
patients; heart failure diagnostics; and meaningful expert analysis through
Medtronic Care Management Services.
In collaboration with leading clinicians, researchers and scientists worldwide,
Medtronic offers the broadest range of innovative medical technology for the
interventional and surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services of the highest
quality that deliver clinical and economic value to healthcare consumers and
providers around the world.
Medtronic offers the broadest range of innovative medical technology for the
interventional and surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services of the highest
quality that deliver clinical and economic value to healthcare consumers and
providers around the world.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.